A Cooking and Eating Study (ACES)

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ClinicalTrials.gov Identifier: NCT01079845

Recruitment Status
:
Terminated
(For this pilot, we constructed conditional power curves and noted that we would not substantially enhance power by enrolling additional participants.)

Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents in susceptible girls around the time of menarche. Females with PCOS have high levels of androgens (e.g., testosterone). While cosmetic appearance (excess facial hair and acne) and menstrual disturbances were once considered the primary concerns, emerging data indicate that many adolescents and young adults with PCOS are insulin resistant and at increased risk for metabolic syndrome and diabetes. The majority of females with PCOS are obese, and excess body fat amplifies the severity of the syndrome.

Dietary intervention is considered an important component of treatment for PCOS. However, a consensus statement regarding optimal nutrient composition for treating adolescents and young adults with PCOS has not been published because data are lacking to provide a foundation for such a statement. Recognizing increased risk for diabetes in patients with PCOS, many practitioners employ a low-fat diet as prescribed in the Diabetes Prevention Program (DPP) for weight loss and control of symptoms.

Objective and Hypothesis. The purpose of this research study is to compare different diets for treating PCOS. We hypothesize that a low-glycemic load diet - designed to lower blood levels of glucose and insulin - will be more beneficial than a low-fat diet in obese adolescents and young adults with PCOS.

Design. We propose a 6-month study in which 50 obesefemales with PCOS (ages 13 to 21 years) will be assigned to receive one of two dietary treatments, with the goal of retaining 40 participants. Group assignment will be at random. One of the treatments will be a low-glycemic load diet, and the other treatment will be a low-fat diet (modeled after the DPP diet). Participants in both groups will receive individual nutrition education and dietary counseling with a registered dietitian (clinic visits, telephone calls) and cooking workshops with a chef. The purpose of the cooking workshops will be to enhance compliance with diet prescriptions, beyond what can be achieved by nutrition education and dietary counseling in a conventional clinic setting.

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Ages Eligible for Study:

13 Years to 21 Years (Child, Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosis of PCOS.

Aged 13 to 21 years (and living at home with a parent, only for those <18 years old).

Body mass index (BMI) at or above the 85th percentile.

Access to a working telephone.

At least one parent willing and able to participate in the intervention, only for those <18 years old.

Residing in predominately one household (no more than one weekend every two weeks in a secondary household).